Veru(US:VERU)2020-08-13 14:58Financial Data and Key Metrics Changes - For Q3 fiscal year 2020, net revenues increased by 6% to $10.3 million from $9.7 million in the prior year [28] - Year-to-date fiscal 2020 net revenues were up 34% to $30.8 million from $23.1 million in the prior year period [32] - The company reported a net loss of $3 million, or $0.05 per diluted common share, compared to a net loss of $2.8 million, or $0.04 per diluted common share in the prior year third quarter [31] Business Line Data and Key Metrics Changes - The U.S. FC2 prescription business saw net revenues up 23% to $5.4 million from $4.4 million in the prior year third quarter [28] - Net revenue from the public health sector business was $4.3 million compared to $4.9 million in the prior year third quarter [28] - FC2 unit sales declined slightly by 3% to 10.5 million units from 10.9 million units in the prior year third quarter [28] Market Data and Key Metrics Changes - The global market for prostate cancer treatments is estimated to represent about $5 billion annually, with no FDA-approved drugs for the indication targeted by VERU-111 [12] - The androgen deprivation therapy market is valued at $2.8 billion globally, with a shift towards GnRH antagonists over LHRH agonists [17] Company Strategy and Development Direction - The company is focused on developing novel medicines for prostate cancer, with plans for two Phase 3 registration trials in 2021 [7] - The transformation into an oncology biopharmaceutical company is nearly complete, supported by a growing revenue-generating sexual health business [41] - The company plans to submit an NDA for TADFIN, a combination of Tadalafil and Finasteride for BPH, by late 2020 [7] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued revenue growth and the ability to invest in clinical development programs due to strong performance in the sexual health business [39] - The company anticipates a steady flow of positive news regarding clinical trials and expects to start the Phase 3 registration study in early 2021 [39][40] Other Important Information - The company received positive FDA input for the proposed Phase 3 trial program for VERU-111, which is designed to evaluate efficacy and safety in men with metastatic castration-resistant prostate cancer [11] - The FC2 manufacturing facility in Malaysia has resumed operations, consistent with pre-COVID-19 volumes [29] Q&A Session Summary Question: Will there be new data presented for VERU-111 at ESMO? - Yes, additional efficacy and safety data will be presented, including tumor response images [44] Question: Is there a chance of getting emergency use authorization for the COVID program? - While some believe it is possible, the company is more likely to proceed with a Phase 3 study depending on the outcomes [48] Question: Will the commercial business be sufficient to fund operations? - The commercial business is expected to generate substantial revenue, potentially funding a significant portion of the Phase 3 trials [55] Question: Are there plans to add more products to the commercial business? - Yes, the company is considering adding more products to leverage the telemedicine channel for additional revenue [59]